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Enrolling by invitation NCT06223074

Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration

Phase II Interventional Multiple Sclerosis Relapsing Remitting Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IV Methylprednisolone administration, Nasal Methylprednisolone (MT).
Who it may be relevant to
Registry conditions: Multiple Sclerosis Relapsing Remitting, Treatment. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone

Overview

This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis

Detailed description

This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.

Interventions

  • Other IV Methylprednisolone administration
    Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse
  • Drug Nasal Methylprednisolone (MT)
    Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse

Primary outcome measures

  • Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments [Time frame: Days 0 and 30 after treatment]
Secondary outcome measures (1)
  • Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment [Time frame: Days 0, 5 and 30 after treatment]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years.
  • Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
  • Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
  • No contraindication for the administration of MP.
  • Agree to participate in the study by means of a signed informed consent

Exclusion criteria

  • Intake of anti-inflammatory steroids in the last 3 days.
  • Patients with active bacterial, viral or fungal infections or undergoing treatment.
  • Patients with hypertension.
  • Patients with diabetes mellitus.
  • Patients with hypo or hyperthyroidism.
  • Patients with glaucoma.
  • Patients with neoplasms.
  • Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
  • Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.
  • Breastfeeding patients.
  • Patients with a history of resistance to glucocorticoids.
  • Patients with a history of severe adverse reactions to glucocorticoids.
  • Patients with a history of hyposmia or anosmia.
  • Patients diagnosed with active sinusitis.
  • Patients with allergic rhinitis.
  • Patients with upper respiratory tract infections.
  • deviated septum
  • History of nasal surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Instituto Nacional de Neurología y Neurocirugía — Mexico City

Identifiers

NCT: NCT06223074 · BD2012-34CEC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗